ANDA 209554, held by Pharmobedient. Tobramycin.
As of Nov 15, 2026, ANDA 209554 (Tobramycin), held by Pharmobedient, was first approved by FDA on Oct 13, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin300MG/5ML · solution;inhalation | Tobramycin | Discontinued |
| Feb 16, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 13, 2017 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
